Phase 2 Study of Combination Treatment Using Cemiplimab, Motixafortide, Gemcitabine, and Nab-Paclitaxel in Patients with Untreated Metastatic Pancreatic Adenocarcinoma

What this Trial Is About

Researchers are evaluating a combination treatment for patients with metastatic pancreatic adenocarcinoma who have not received prior therapy. This Phase 2 open-label study aims to assess whether adding motixafortide, a CXCR4 antagonist, to standard chemotherapy gemcitabine and nab-paclitaxel and immunotherapy cemiplimab can reduce tumor size, extend patient survival, and be safely tolerated. Motixafortide has shown promise in laboratory studies to enhance immunotherapy effects, but its combination with cemiplimab and standard chemotherapy is being tested for the first time in this trial. Participants will first receive motixafortide alone daily for 5 days in a priming phase, followed by motixafortide twice weekly. Cemiplimab is administered intravenously once every 21 days, while gemcitabine and nab-paclitaxel chemotherapy are given intravenously on days 1, 8, and 14 of each 28-day cycle. If serious side effects occur, the treatment plan may be adjusted. The combination uses FDA-approved chemotherapy doses and cemiplimab dosing approved for skin cancer. Participants will be closely monitored throughout the study with assessments of tumor response at 16 weeks using immune-modified RECIST criteria. Researchers will track overall response rate, treatment-related toxicities, progression-free survival, overall survival, duration of clinical benefit, and disease control rate for up to 5 years. Safety evaluations include blood tests, imaging, and biopsies. The study requires informed consent and adherence to protocol, with ongoing follow-up to understand the long-term impact of the combination treatment.

Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma